FDA Approves Innoviva’s IV Treatment for Difficult-to-Treat Bacterial Pneumonia

The FDA has approved Innoviva Specialty Therapeutics’ Xacduro (sulbactam for injection; durlobactam for injection) for treatment of hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia (HABP/VABP).

The co-packaged drug treats infection caused by susceptible isolates of Acinetobacter baumannii-calcoaceticus (Acinetobacter) complex in patients ages 18 years and older. Acinetobacter is resistant to penicillin and has acquired resistance genes for almost all antibiotics used to treat gram-negative bacteria, including fluoroquinolones, aminoglycosides, cephalosporins, and carbapenems.

Xacduro’s two drugs — sulbactam, a drug structurally related to penicillin, and durlobactam — play different roles in the treatment. Sulbactam kills Acinetobacter and durlobactam protects sulbactam from being degraded by enzymes that Acinetobacter may produce.

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